Merck & Co.
) recently presented new data on its insomnia candidate,
suvorexant, at the 21st Congress of the European Sleep Research
Society (ESRS). Data from a 2-month discontinuation phase post a
12-month phase III study was presented.
It was found that patients who switched to placebo from suvorexant
after 12 months, experienced greater difficulty in falling asleep
(14.9 minutes longer) and staying asleep (21.6 minutes less) than
the patients who continued to take suvorexant. The sleep
difficulties experienced by patients who switched from suvorexant
to placebo and patients who received placebo during the 12-month
trial and continued to receive placebo during the discontinuation
phase, were similar.
Importantly, there were no significant withdrawal symptoms or
rebound insomnia observed in patients who switched from suvorexant.
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In June 2012, Merck had announced new data from two pivotal phase
III efficacy trials of suvorexant. Results showed that patients on
suvorexant took less time to fall asleep and stayed asleep for a
longer time period compared to placebo. Merck expects to file for
approval by year end. The company expects the Controlled Substance
Staff of the Food and Drug Administration (FDA) to evaluate the
candidate before final approval.
If approved suvorexant will be enter the highly genericized
insomnia market which includes generic versions of
) Ambien/Ambien CR and
) Sonata. Other products in this market include Dainippon Sumitomo
Pharma's Lunesta and Purdue Pharma/
We currently have a Neutral recommendation on Merck, which carries
a Zacks #3 Rank (short-term Hold rating). Merck is currently facing
issues such as the patent expiration of Singulair, EU pricing
pressure, US health care reform, the Remicade/Simponi transition
and pipeline setbacks.
We believe the company will continue resorting to cost-cutting
initiatives to drive the bottom line. Meanwhile, some of the
company's recent launches should start contributing significantly
to the top line in the forthcoming quarters.